Recall Z-0949-2015— St Jude Medical Cardiac Rhythm Management Division
Class II · Terminated
Class II FDA medical device recall by St Jude Medical Cardiac Rhythm Management Division, initiated 2014-12-18, terminated 2016-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter. Reason: Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers..
- Recalling firm
- St Jude Medical Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-18
- Terminated
- 2016-03-30
- Firm location
- Sylmar, CA, United States
Product description
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Reason for recall
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.